New Delhi, Health Helpline: The Food and Drug Administration (FDA) has approved Veklury® (Remdesivir; Gilead Sciences) for the treatment of coronavirus disease 2019 (COVID-19) in patients aged 12 years and older (weighing at least 40kg) requiring hospitalization.
Veklury is a nucleotide analogue with a broad-spectrum antiviral activity that should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Previously, the product was available under an Emergency Use Authorization (EUA) for hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, regardless of disease severity.
The approval was supported by data from three phases 3 trials in hospitalized patients with mild to severe COVID-19. The randomized, double-blind, placebo-controlled phase 3 ACTT-1 trial assessed 1062 hospitalized patients with COVID-19 who received either Veklury (n=541) or placebo (n=521) in addition to standard of care. The primary endpoint was the time to recovery, defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.
Results showed that the median time to recovery was 10 days for the Veklury treatment arm compared with 15 days for placebo (rate ratio 1.29; 95% CI: 1.12, 1.49; P <.001). The odds of improvement at Day 15 were also statistically significantly higher for Veklury compared with placebo (odds ratio 1.54; 95% CI: 1.25, 1.91). In the overall patient population, Veklury showed a trend toward reduced mortality at Day 29 compared with placebo (11.4% vs 15.2%; hazard ratio [HR] 0.73; 95% CI: 0.52, 1.03).
Additionally, the efficacy of Veklury was assessed in two multicenter, randomized, open-label phase 3 trials (SIMPLE-Severe and SIMPLE-Moderate) in adults with severe and moderate COVID-19, respectively. The SIMPLE-Severe trial evaluated a 5-day (n=200) and 10-day (n=197) treatment course with Veklury in hospitalized patients who required supplemental oxygen and were not mechanically ventilated. Findings showed that a 5-day or a 10-day treatment with Veklury achieved similar outcomes (odds ratio 0.75; 95% CI: 0.51, 1.12).
The SIMPLE-Moderate trial compared a 5-day (n=191) and 10-day (n=193) treatment with Veklury to the standard of care (n=200) in hospitalized patients who did not require supplemental oxygen. Results showed that a 5-day treatment with Veklury had significantly improved clinical outcomes compared with standard of care (odds ratio 1.65; 95% CI: 1.09, 2.48; P =.017). Moreover, the odds of improvement in clinical status with the 10-day treatment were favorable, but not statistically significant vs standard of care (odds ratio 1.31; 95% CI: 0.88, 1.95).
With regard to safety, the most common adverse reactions for Veklury included nausea, increased ALT, and increased AST. Veklury was associated with a similar frequency of adverse events to placebo in the ACTT-1 trial with higher rates of serious adverse events in the placebo arm.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” said FDA Commissioner Stephen M. Hahn, MD. “The agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
The FDA has also issued a new EUA for the use of Veklury to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients under 12 years of age weighing at least 3.5kg or hospitalized pediatric patients weighing 3.5kg to less than 40kg for whom the use of an intravenous (IV) agent is clinically appropriate.
Veklury is available as single-dose vials containing 100mg of remdesivir in either lyophilized powder or aqueous-based solution.